Applying the ‘Human Rights Model of Disability’ to Informed Consent: Experiences and Reflections from the SHAPES Project
Abstract
:1. Introduction
The SHAPES Project
- (1)
- Smart Living Environment for Healthy Ageing at Home;
- (2)
- Improving In-Home and Community-based Care;
- (3)
- Medicine Control and Optimisation;
- (4)
- Psycho-social and Cognitive Stimulation Promoting Well-being;
- (5)
- Caring for Older Individuals with Neurodegenerative Diseases;
- (6)
- Physical Rehabilitation at Home;
- (7)
- Cross-border Health Data Exchange Supporting Mobility and Accessibility for Older Individuals.
2. The Human Rights Model of Disability as a Theoretical Framework
3. Participation of “Vulnerable Adults” in Research Projects: A Review of the Relevant Literature
3.1. Participatory Research
3.2. Participation of “Vulnerable Adults” in Research Projects
4. Conceptual, Legal, and Procedural Challenges: The Winding Road toward Enacting Participatory Research in line with the Human Rights Model
4.1. Conceptual Challenges
4.2. Legal Challenges
4.3. Procedural and Practical Challenges
5. How to Address Those Challenges? The Approach Enshrined in SHAPES
- Providing the legal basis for consent: ensuring that there are sufficient capabilities for asking consent as part of the service and that the consent is documented properly (obligatory), and building up a repository where consents can be collected centrally (optional, contingent upon value to the SHAPES project).
- Providing a process for the implementation of services for single end-users (older persons) and for the assessment of the suitability of the services from time to time (including a process to assess the digital literacy of the end-user and adapt the services according to end-user needs and capabilities). The process should include more time to discuss choices or have an advocate regarding important appointments in order to make notes and help the person understand or remember choices.
- Providing a detailed process, taking into consideration national laws, to determine if the older person is able to decide on accessing the services and, secondly, if they are able to give informed consent and re-consent for the collection of the information.
- Providing understandable and plain-language materials, instructions, and information in visual form (including information on each service and how it operates and what data it collects) and providing video-based instructions for the end-user (older persons).
- An explanation of why the research is being conducted.
- Who is organising and funding the research?
- Why am I being asked to take part?
- How will the research be conducted?
- What will happen if I agree to take part?
- What are the benefits/What are the risks?
- Is the research confidential?
- Information on data protection (specifically GDPR regulations).
- Where can I get further information?
- How do I withdraw consent?
5.1. Guidelines for Informed Consent Processes
5.1.1. Rights-Based Approach
5.1.2. Accessibility Measures
5.1.3. Allow for Decision-Making Supports
5.1.4. Decision-Making as a Cyclical Process and (Re) Evaluation
6. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
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Lombard-Vance, R.; Soye, E.; Ferri, D.; McEvoy, E.; MacLachlan, M.; Sarlio-Siintola, S. Applying the ‘Human Rights Model of Disability’ to Informed Consent: Experiences and Reflections from the SHAPES Project. Disabilities 2023, 3, 28-47. https://doi.org/10.3390/disabilities3010003
Lombard-Vance R, Soye E, Ferri D, McEvoy E, MacLachlan M, Sarlio-Siintola S. Applying the ‘Human Rights Model of Disability’ to Informed Consent: Experiences and Reflections from the SHAPES Project. Disabilities. 2023; 3(1):28-47. https://doi.org/10.3390/disabilities3010003
Chicago/Turabian StyleLombard-Vance, Richard, Evelyn Soye, Delia Ferri, Emma McEvoy, Malcolm MacLachlan, and Sari Sarlio-Siintola. 2023. "Applying the ‘Human Rights Model of Disability’ to Informed Consent: Experiences and Reflections from the SHAPES Project" Disabilities 3, no. 1: 28-47. https://doi.org/10.3390/disabilities3010003